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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 18 and 75 years of age
Distal diminution of either vibration sensation or pain or temperature sensation in the legs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test the feasibility and safety of high-concentration capsaicin patches for treating pain associated with HIV neuropathy.
Who is the study for?
Adults aged 18-75 with painful HIV-associated neuropathy, stable on certain medications, and without recent neurotoxic drug exposure can join. They must not have a high opioid tolerance or sensitivity to capsaicin or Roxicodone®, no implanted pain devices, active infections, other significant pain causes, or untreated major organ issues.Check my eligibility
What is being tested?
The trial is testing the use of high-concentration capsaicin patches for relieving pain in patients with HIV-related nerve pain. It aims to assess how tolerable and effective this treatment is compared to existing options.See study design
What are the potential side effects?
Potential side effects include local skin reactions at the patch application site such as redness and burning sensation, possible increase in blood pressure during application, coughing or sneezing fits due to airborne capsaicin particles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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I have reduced feeling of vibration or temperature in my legs.
Select...
The skin over my painful area is healthy and unbroken.
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I am a woman who can have children and have a negative pregnancy test.
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My ankle reflexes are weak or not present.
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I've been on a stable pain medication plan for at least a week and can keep it the same during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
NeurogesXLead Sponsor
16 Previous Clinical Trials
2,481 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been treated for serious infections in the last 14 days.I am willing to take Roxicodone if needed for treatment discomfort.I do not have any current severe infections, with certain exceptions.I have used pain relief cream or ointment in the last 21 days.I am not currently using any experimental drugs or specific heart rhythm medications.I have no major untreated issues with my heart, kidneys, liver, or lungs.I am willing to take Roxicodone if needed for treatment discomfort.I am between 18 and 75 years old.I have had painful foot discomfort due to HIV for over 2 months.I have reduced feeling of vibration or temperature in my legs.I haven't taken any neurotoxic HIV drugs in the last 8 weeks or have been on a stable dose for at least 8 weeks.The skin over my painful area is healthy and unbroken.I am a woman who can have children and have a negative pregnancy test.I have had painful foot discomfort due to HIV for at least 2 months.My ankle reflexes are weaker or absent compared to my knees.I have a known cause for my nerve pain other than cancer.I currently have active cancer.I have a high tolerance to pain medications, making Roxicodone ineffective for me.My ankle reflexes are weak or not present.I've been on a stable pain medication plan for at least a week and can keep it the same during the study.I have significant pain not caused by HIV-related nerve pain.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT00061152 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age limit for this clinical trial extend to people under 25 years of age?
"This study is open to people aged 18-75. There are 188 other trials available for those under 18 and 631 for seniors above 65 years old."
Answered by AI
Has this particular medication been approved by the Federal Drug Administration?
"While there is data suggesting this treatment may be safe, it only exists in Phase 2 trials. This means that, currently, there is no evidence to support its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
NeurogesX Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have neuropathy in both feet for there years as a result of taking Taxotere to treat breast cancer.
PatientReceived no prior treatments
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